Norav 1200 Series PC-ECG
- Primary DI
- 07290110255107
- Brand
- Norav 1200 Series PC-ECG
- Company
- NORAV MEDICAL LTD.
- Model
- 1200W Kit
- Catalog number
- 1200W2-K-00-U-C10-17
- Device description
- Kit includes: PC-ECG 1200W (UDI: 07290110252076) wireless Stress-Test Kit; Input cable with ten leads AHA type and Clip connectors; Waiste Belt for mounting the wireless transmitter at Patient's hip.
- Published
- 2019-09-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07290110255107 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290110255107 | 07290110255107 | 7290110255107 |
GMDN Terms
| Term | Definition |
|---|
| Electrocardiography telemetric monitoring system transmitter | A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device. |
Contacts
| Phone | Email |
|---|
| +97249893001 | info@norav.com |
Regulatory Flags
- DUNS number
- 514773159
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 07290110255497 | Norav 1200 Series PC-ECG | 1200HRT | 1200HRT-D-00U-03 | 2020-06-03 |
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| 07290110254902 | Norav NR Series | NR1207-3 Kit | NR12073-K-00-EB10S5-02 | 2019-10-01 |
| 07290110254919 | Norav NR Series | NR1207-3 Kit | NR12073-K-00-UB10S5-01 | 2019-10-01 |
| 07290110255206 | Norav NR Series | NR1207-E Kit | NR1207E-K-00-E-01 | 2019-10-01 |
| 07290110255213 | Norav NR Series | NR1207-3 Kit | NR12073-K-00-E-01 | 2019-10-01 |
| 07290110255343 | Norav NR Series | NR1207-3 Kit | NR12073-K-00-E-02 | 2019-10-01 |
| 07290110255404 | Norav NR Series | NR1207-E Kit | NR1207E-K-00-E-B10-06 | 2019-10-01 |
| 07290110253035 | Norav NR Series | NR302 | NR302-D-00E-01 | 2019-09-30 |
| 07290110253042 | Norav NR Series | NR302 Kit | NR302-K-00-E-S7-01 | 2019-09-30 |
| 07290110253059 | Norav NR Series | NR314 | NR314-D-00E-01 | 2019-09-30 |
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